Gemcitabine And Oxaliplatin Followed By Radiation Therapy, Fluorouracil, And Oxaliplatin In Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

Study Overview

Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

OBJECTIVES: Primary * Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin. Secondary * Determine the tolerability of this regimen, in both the short- and long-term, in these patients. * Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. * Determine the clinical benefits of this regimen in these patients. * Determine locoregional and metastatic progression-free survival of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. * Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy. * Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Pancreatic Cancer

DRUG: fluorouracil
DRUG: gemcitabine hydrochloride
DRUG: oxaliplatin
RADIATION: radiation therapy

CDR0000454568
GERCOR-D03-1
EU-20570
SANOFI-GERCOR-D03-1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-01-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2009-02-06
First Submitted that Met QC Criteria 2006-01-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2009-02-09
First Posted (ESTIMATED) 2006-01-11	Results First Posted N/A	Last Verified 2006-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Progression-free survival

Secondary Outcome Measures	Measure Description	Time Frame
Tolerability
Recurrence-free survival
Overall survival
Response rate
Quality of life
Clinical benefits
Locoregional and metastatic progression-free survival

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed adenocarcinoma of the pancreas

Locally advanced, nonresectable disease
Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery
No visceral or peritoneal metastases
No adenocarcinoma of the bile ducts or the ampulla of Vater

ECOG performance status 0-2
Stable or controlled pain with analgesics
Not pregnant or nursing
Neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 times normal OR < 3 mg/dL
Creatinine clearance ≥ 40 mL/min
Bilirubin ≤ 1.5 times normal
Alkaline phosphatase < 5 times normal
No medical condition that would preclude study treatment
No active infection
Negative pregnancy test
No serious cardiac or respiratory disease
No uncontrolled or persistent hypercalcemia
No pre-existing neuropathy
No biliary or gastro-duodenal obstruction
No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder
No familial, social, geographical, or psychological condition that would preclude study compliance

See Disease Characteristics
No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)
At least 2 months since prior radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Laurence Moureau-Zabotto, MD, Institut Paoli-Calmettes

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Moureau-Zabotto L, Phelip JM, Afchain P, Mineur L, Andre T, Vendrely V, Lledo G, Dupuis O, Huguet F, Touboul E, Balosso J, Louvet C. Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: a Groupe Coordinateur Multidisciplinaire en Oncologie phase II study. J Clin Oncol. 2008 Mar 1;26(7):1080-5. doi: 10.1200/JCO.2007.12.8223.
Moureau-Zabotto L, Phélip J, Afchain P, et al.: Concomitant administration of weekly oxaliplatin, 5FU continuous infusion and radiotherapy in locally advanced pancreatic cancer (LAPC): a Gercor phase II study. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1077, S173-4, 2006.

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